Senior Auditor, QA
1 day ago
Conduct audits to assess compliance with applicable regulations, company policies, standard operating procedures and (SOPs) work instructions (WI), contracts and project-specific requirements. Hosts and supports customer audits and regulatory inspections in accordance with QA SOPs and WIs. Provides guidance to less experienced QA auditors.
Syneos Health Audits
- Plans and conducts assigned audits.
- Performs For Cause audits
- Writes and issues audit reports, ensuring clear communication of audit findings to the auditees and relevant management.
- Reviews responses to audit findings for appropriateness and completeness.
- Closes assigned audits.
Customer Audits/Inspections
- Prepares for and hosts or supports customer audits.
- Prepares for and hosts or supports Regulatory Authority Inspections.
Other
- Serves as Lead Auditor on team-based Syneos Health audits.
- Serves as a trainer and mentor to less experienced QA auditors.
**Supervision**
- Requires mínimal instructions on day-to-day work and new assignments.
**Other tasks**
- May write, review or revise QA Standard Operating Procedures (SOPs) / Work Instructions (WIs).
- Performs other work-related duties as assigned.
- Moderate travel may be required (up to 50%).
**Requirements**:
- Requires a Bachelor’s degree in the science/health care field or equivalent with extensive experience in GxP quality assurance auditing.
- 2 years of relevant experience as an auditor in GCP
- Previous experience in the conduct of multiple audit types (e.g. vendors, investigator sites, trial master files, data management, safety reporting and laboratories) is preferred.
- Excellent Knowledge of GxP regulatory requirements.
- Knowledge of Medical and technical terminology related to the audit types to be conducted.
- Computer literacy commensurate with job requirements (Microsoft Office suite; basic Sharepoint proficiency).
- Able to handle multiple tasks to meet timelines in dynamic environment.
- Strong organizational, presentation and interpersonal skills.
- Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds.
- Ability to negotiate, problem solve and provide constructive feedback.
- Well-developed communication skills and the ability to write concise, accurate reports and other necessary documentation
-
QA/qc Engineer
1 day ago
Singapore Peak Ocean Pte Ltd Full timeJob Details: - Prepare and conduct Project Specific Quality requirements training to production - Supervisors and sub-contractors QC Personnel. - Establishing Work Procedures and Instructions. - Act as Project Lead QA/QC and control the entire project Quality Assurance and Control activities during construction phase. - Oversees the Inspector’s...
-
QA Auditor
7 days ago
Singapore Labcorp Drug Development Full timeResponsibilities : Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample) and review audit responses for completeness Support 'business partner' /liaison meetings representing QA function with operations Report on relevant quality metrics (for single topics/departments) and highlight trends...
-
QA Auditor
7 days ago
Singapore Lonza Full timeToday, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
-
Senior Auditor
3 days ago
Singapore Ashford Benjamin Ltd. Full timeAshford Benjamin are supporting a global financial services firm who have new headcount within their APAC Internal Audit function. Our client is looking for a Senior Auditor who will be responsible for the performing risk-based audits, whilst ensuring the effectiveness of controls and governance processes for the business. The job holder will be responsible...
-
QA Auditor
7 days ago
Singapore Labcorp Full timeConduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample) and review audit responses for completeness Support 'business partner' /liaison meetings representing QA function with operations Report on relevant quality metrics (for single topics/departments) and highlight trends Adhere to required...
-
QA Executive
1 day ago
Singapore SINGAPORE FOOD DELIGHT MANUFACTURER PTE. LTD. Full time**Responsibilites**: - Document control Management (ISO2200,FSCC,HACCP,Halal and other safety-related documentation) - Conduct in-process and hygiene inspections. - Perform QC experiments on raw materials as well as a finished products to ensure the product meets the defined criteria before its release to the market. - Involvement in all QA / product...
-
QA Manager
2 weeks ago
Singapore FU YU CORPORATION LIMITED Full timeKey Responsibilities Develop, implement, and maintain Quality Management Systems (e.g., ISO 9001, ISO 13485). Lead and mentor the QA team, providing training and guidance. Oversee inspection and testing of raw materials, in-process items, and finished products. Drive continuous improvement initiatives using Lean or Six Sigma methodologies. Ensure compliance...
-
Assistant QA Manager
1 week ago
Singapore Leong Hup Food Pte Ltd Full time**Education and Work Requirements**: - Minimum a Degree in Food Science/ Technology and other relevant discipline - Minimum 7 years of relevant experience in Food Manufacturing - Minimum 5 years of relevant experience in handling FSMS - Knowledgeable in establishing, maintaining and updating FSSC 22000 - Certified ISO 22000/FSSC 22000 Internal Auditor; Lead...
-
Senior QA/qc Engineer
2 weeks ago
Singapore Peak Ocean Pte Ltd Full timeResponsibilities: - Prepare and conduct Project Specific Quality requirements training to production Supervisors and Sub-contractors QC Personnel - Establish Work Procedures and Instructions - Support QA/QC Manager in establishing WPS, PQR and WQT Qualifications. - Act as Project Lead QA/QC and control the entire project Quality Assurance and Control...
-
Senior QA Officer
2 days ago
Singapore INDOGUNA (SINGAPORE) PTE LTD Full timeResponsibilities To manage, maintain and implement Food Quality and Safety Management System. To enforce Food Quality and Safety Policy, MSC COC Policy and Procedures in the company premise. To conduct daily/weekly routine validation inspection to ensure compliance (CCP, RPR, OPRP, GMP, GHP, MSC) and identify problematic areas for improvement. To investigate...